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Could a common osteoporosis drug stop bone tumors from coming back?

NCT ID NCT03295981

Disease control Sponsor: St. Louis University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding zoledronic acid (a bisphosphonate) to bone cement during surgery can lower the chance of a giant cell tumor of bone returning. About 120 people with primary tumors in their arms or legs will be randomly assigned to receive either standard surgery or surgery with the drug. The main goal is to see if the drug reduces local recurrence rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zoledronic acid (bisphosphonate) added to bone cement
What this could lead to
If it works, this could offer a simple way to lower the chance of a giant cell tumor coming back after surgery, reducing the need for repeat operations.
What could go wrong
This is a relatively small trial (120 people) and results may not apply to all patients. There is also a risk of surgical site infection or other complications from the added drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary benign GCT of bone * Lesion located in an extremity * Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal * No previous systemic bisphosphonate or denosumab therapy Exclusion Criteria: * Recurrent GCT of bone * Non-extremity location * Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component * Children and pregnancy * Previous systemic bisphosphonate or denosumab therapy

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Conditions

The condition(s) this trial relates to.

bone giant cell tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell tumor of bone

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Science

    RECRUITING

    New Delhi, 110029, India

  • Allegheny-Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre

    COMPLETED

    Montreal, Quebec, H3G 1A4, Canada

  • Saint Louis University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • University of California - Los Angeles

    RECRUITING

    Los Angeles, California, 90404, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    COMPLETED

    Overland Park, Kansas, 66211, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Washington

    COMPLETED

    Seattle, Washington, 98195, United States

  • Wake Forest University

    COMPLETED

    Winston-Salem, North Carolina, 27157, United States

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